CN103269739A

CN103269739A - Needle safety device and assembly

Info

Publication number: CN103269739A
Application number: CN2011800483196A
Authority: CN
Inventors: K.韦尔
Original assignee: B Braun Melsungen AG
Current assignee: B Braun Melsungen AG
Priority date: 2010-08-05
Filing date: 2011-07-26
Publication date: 2013-08-28
Anticipated expiration: 2031-07-26
Also published as: US10661058B2; ZA201300873B; CN103269739B; EP2600925B9; RU2013109410A; EP2600925A1; EP3878496A1; RU2016101256A3; EP3058976B1; PT2600925T; MY163592A; US20120035552A1; US20170209675A1; RU2020123566A3; CO6680648A2; CN112089950B; EP3967344A1; PL2600925T3; EP2600925B1; WO2012016660A1

Abstract

Safety intravenous catheters (IVCs) are disclosed herein having a catheter hub (102) with a catheter tube (112), a needle with a needle hub, and a needle guard (204). The needle guard is configured to be positioned at least partially within an interior space of the catheter hub and is retained thereto by mechanical engagement between the two. Following removal of the needle from the catheter hub, the needle guard is configured to disengage from the catheter hub and attach over a tip of the needle to shield the needle tip from inadvertent needlesticks. The needle guard having an angled end section configured with a length and a width to retain the needle tip within a tip holding space behind the angled end section.

Description

Pin safety device and assembly

The cross reference of related application

This is the normal patent application of the U.S. Provisional Application submitted on August 5th, 2010 number 61/371,054, and its content is attached to herein by reference clearly.

Background technology

Disclosure relate generally to pin security component and safe vein inner catheter (IVC), and relate to especially after pin is regained and automatically cover needle point to prevent the safety IV C of the involuntary acupuncture of needle point.

Background technology

Intravenous catheter is mainly used to directly give fluid in the patient's blood vessel system.Usually, by the health care workman conduit is inserted in patient's the vein.And then pin is after patient's vein is regained, and the needle point of exposure has formed the danger that accidental needle sticks takes place immediately, and this blood that makes the health care workman be vulnerable to various danger carries the infection of pathogen.

This danger has caused developing uses multiple means of different to cover or the safety IV C of hiding needle point.Yet some the safety IV C that has developed fails to prevent the generation of involuntary acupuncture sometimes.For example, in some safety IV C, pin rotation during removal may cause needle point to skid off in the boundary of needle shield.

In some safety IV C, be insecure occurring in engaging between pin and the needle shield between the retirement period of pin usually.

Summary of the invention

The various embodiment of safety IVC have a plurality of features, do not have which feature only to be responsible for the attribute of its expectation in these features.Now the principal character of these embodiment will be discussed briefly under the situation of the scope that is not intended to limit embodiment described herein.

In certain embodiments, comprise a kind of needle shield, this needle shield comprises nonmetal base portion, and nonmetal base portion comprises the hole, towards the surface of nearside and towards the surface in distally.This sheath also comprises the first free-ended the first arm and comprises second free-ended second arm that the first arm and second arm roughly axially extend along distal direction from base portion.First free end extends beyond second free end and comprises the inclined end portion section (angled end section) that extends towards second arm.Wherein, inclination distal end section comprises that the pin that is configured to have the pin diameter remains on needle point and keeps length and width in the space, and wherein, the length of inclination distal end section and width are greater than the pin diameter.

In other embodiments, provide a kind of conduit tube component that comprises needle shield, this needle shield comprises nonmetal base portion, and nonmetal base portion comprises the hole, towards the surface of nearside and towards the surface in distally.This sheath comprises the first free-ended the first arm and comprises second free-ended second arm that the first arm and second arm roughly axially extend along distal direction from base portion.First free end extends beyond second free end, and comprises the inclined end portion section, and this inclined end portion section comprises length and the width that extends towards second arm and the pin with diameter.Wherein, the first arm and second arm are biased between ready position and protected position mobile, and in ready position, the inclined end portion section is in abutting connection with the pin with needle point, and in protected position, needle point is limited in needle point and keeps in the space.Wherein, the length of inclined end portion section and width are greater than the pin diameter.

In another embodiment, provide a kind of safety IV C, it comprises the pin hub (hub) with pin, the catheter hub with duct conduits and needle tip protector.Needle tip protector is made by first material and is had proximal wall and two arms; proximal wall comprises the opening of limiting hole; two arms are at the distal extension of proximal wall, and at least one in the described arm comprises the inclined end portion section, and the inclined end portion section is formed at the far-end that protective position covers another arm.Wherein, comprise that the insert of being made by second material of opening is aimed at the opening of proximal wall, and wherein, the opening of proximal wall requires opening power still less than insert in order to enlarge.

Another embodiment of this assembly comprises needle assembly, and this needle assembly comprises nonmetal base portion, nonmetal base portion comprise have the hole, the wall of hole length, bore dia, towards the surface of nearside and towards the surface in distally.This sheath also comprises the first free-ended the first arm and comprises second free-ended second arm, the first arm and second arm roughly axially extend along distal direction from base portion, first free end extends beyond second free end and comprises the inclined end portion section, and this inclined end portion section comprises first side edge, second side edge, length and the width that extends towards second arm.This sheath comprises that the needle point that is limited by base portion, the first arm, second arm and inclined end portion section at least in part keeps the space.This assembly also comprises the pin with needle point and diameter.Wherein, the first arm and second arm are biased between ready position and protected position mobile; in ready position; the inclined end portion section is in abutting connection with pin; in protected position, needle point is limited in needle point and keeps in the space, and wherein; the length of inclined end portion section and width be greater than the pin diameter, and cooperate with hole length and bore dia and to keep in the space needle point is limited in needle point.

Another feature of the application is a kind of method for the assembling needle assembly.This method comprises: provide pin at the pin hub, this needle set has shank, needle point and near the profile variations needle point; And place needle shield slidably around shank.Needle shield comprises nonmetal base portion, nonmetal base portion comprise have the hole, the wall of hole length, bore dia, towards the surface of nearside and towards the surface in distally.This needle shield also comprises the first free-ended the first arm and comprises second free-ended second arm, the first arm and second arm roughly axially extend along distal direction from base portion, first free end extends beyond second free end and comprises the inclined end portion section, and this inclined end portion section comprises first side edge, second side edge, length and the width that extends towards second arm.This needle shield comprises that also the needle point that is limited by base portion, the first arm, second arm and inclined end portion section at least in part keeps the space.The length of wherein, inclination distal end section and width cooperate greater than the pin diameter and with hole length and bore dia and keep in the space needle point is limited in needle point.This method also comprises makes needle shield move to proximal position on the shank, makes the inclined end portion section be setovered by shank and spaced apart with needle point.

Description of drawings

To focus on now and emphasize that favorable characteristics discusses the various embodiment of this needle assembly and safety IV C.These embodiment have described the novelty shown in the accompanying drawing and non-obvious safety IV C, and accompanying drawing only is for illustration purposes.These figure comprise that with figure below wherein identical reference number is represented identical part:

Fig. 1 is the top view according to the safety catheter hub with alar part of embodiment;

Fig. 2 is the profile according to the safety catheter hub of Fig. 1 that comprises pin of embodiment;

Fig. 2 A is the profile of the modified safety catheter assembly that provides according to embodiment;

Fig. 3 A is the side view according to the needle shield of various embodiment;

Fig. 3 B is the end-view along the needle shield of Fig. 3 A of line 3B-3B acquisition;

Fig. 3 C is schematic top view or the plane graph of needle shield of Fig. 3 A of the relation between describing;

Fig. 4 A is the side view according to the protected locational needle shield of various embodiment;

Fig. 4 B is the cutaway view of the needle shield of Fig. 4 A;

Fig. 5 is the side view according to the needle shield of various embodiment; And

Fig. 6 is the cutaway view according to the alternate configuration of the needle shield of Fig. 5 of embodiment.

The specific embodiment

The detailed description intention of setting forth below in conjunction with accompanying drawing is as the description of the currently preferred embodiment of the safety IV C that provides according to this equipment, system and method, and be not intended to represent can construct or this equipment of utilization, system and method form only arranged.This description has been set forth and has been used for constructing and feature and the step of the safety IV C of this equipment of use, system and method in conjunction with illustrated embodiment.Yet it should be understood that and to realize function and structure identical or that be equal to the different embodiment that also are intended to covered in the spirit and scope of the present invention.And, as described in other places in this article, the identical indication of reference number intention identical or similar elements or feature.

Some parts of accompanying drawing and written description indication embodiment thereof form, and some miscellaneous part is formed independent part.What one of skill in the art will recognize that is that those parts that are illustrated as in this article and are described as forming can form independent part in replacement scheme.Those of ordinary skills it will be appreciated that also the parts that are illustrated as and are described as forming discrete item in this article can form in alternate embodiment.In addition, term as used herein " one " is described single-piece, and it can individually form or individually embody, and " monomer " means that monolithic ground forms.

Fig. 1 is the diagram according to the conduit shell 100 of embodiment.Conduit shell 100 comprises catheter hub main body 102.Hub main body or catheter hub 102 are limited to the inner room 104(Fig. 2 that extends between the near-end 106 of hub main body 102 and the far-end 108).Hollow tubing conductor pipeline 112 is used known in the industry sleeve pipe or keeper 203(Fig. 2) be attached to far-end 108 places of hub main body 102.Define axially or proximal open 110 at near-end 106 places of hub main body 102.Axially open 110 is configured to receive the hollow needle hub, the hollow needle hub be included on its far-end pin and in the blood back chamber of its proximal end (flash chamber).Axially open 110 can be presented as cloudy Luer taper, and it is typical in the industry.Alternatively, the pin hub is in abutting connection with the end of near-end 106, but do not enter inner room 104.What term as used herein far-end or near-end referred to is respectively in the end of distally general position or nearside general position, perhaps is respectively farthest side end or nearest side end.Represent farthest side end or nearest side end iff intention, then this paper will represent like this.

In certain embodiments, hub main body 102 comprises port one 14, and its direction along the axial direction that is approximately perpendicular to inner room 104 is extended from hub main body 102.In another embodiment, do not comprise port one 14.In another embodiment, this port comprises valve or the piston for the fluid flow of regulating the opening that passes through port one 14.For example, port one 14 and valve can be presented as the needleless inlet valve.In the patent No. 5,439, exemplary needleless inlet valve is disclosed in 451,6,036,171 and 6,543,745, the content of each of these patents is combined in herein by reference clearly.Alternatively or in addition, can use plastics or rubber bushing 82(Fig. 2) control the flow by port one 14, this is well-known in the industry.Lining 82 is formed at shrinkage when applying the fluid pressure that is caused by for example syringe.In certain embodiments, can provide alar part 116 in hub main body 102.Alar part 116 can be positioned to when port one 14 is arranged on the hub main body 102, come out from the hub Subject Extension on the plane perpendicular to port one 14.

Fig. 2 is the profile according to the safety catheter hub 100 of Fig. 1 of embodiment.Usually, as shown in Figure 2, pin 202 is received and extends through inner room 104 by axially open 110.At far-end 108 places of hub main body 102, pin 202 extends in the tubular conduit 112 and passes tubular conduit 112, and needle point extends beyond the far-end of tubular conduit 112.

In one embodiment, comprise protectiveness needle shield 204, protectiveness needle shield 204 is arranged on the pin 202 slidably.Needle shield 204 comprises base portion 205, base portion 205 limiting holes 207, and hole 207 axially extends through base portion 205 in order to receive pin 202.As described in greater detail, hole 207 is configured to allow pin 202 to be received in wherein slidably aspect size and dimension.Needle shield 204 also comprises the first arm 206 and second arm 208, and the first arm 206 and second arm 208 roughly axially extend from base portion 205.

Base portion 205 also comprises wall, and this wall comprises that wall surface 60 dough-making powder wall surface 62(distad towards nearside is also referring to Fig. 3 A).Provide gap 50 between two arms 206,208, gap 50 is limited by the edge of two arms and the wall surface 62 towards the distally of base portion 205.The first arm 206 has first freedom or cantilever end 210 and second arm 208 and has second freedom or cantilever end 212.First free end 210 extends beyond second free end 212 and has inclined end portion section 214, and inclined end portion section 214 can be called wall, protects section, stop tip or medicated cap.Inclined end portion section 214 extends towards second arm 208.In the embodiment shown, inclined end portion section 214, the first arm 206 and base portion 205 form mutually continuously or monolithically.And term as used herein first and second only is identifier, and the physical features of restricted arm not necessarily.For example, when from another viewpoint, the first arm can be called second arm and vice versa.

In one embodiment, needle shield 204 is made by plasticity, thermoplasticity or elastomeric material or its any combination of monomer, such as thermoplastic elastomer (TPE) (TPE).For example, needle shield 204 can be made by shape memory elastic body, makes the first arm 206 setover automatically towards second arm, and the end of inclined end portion section 214 and second arm is overlapping at least in part.The use of shape memory or elastomeric material allows needle shield 204 to be biased to closure or protectiveness position automatically under the situation that does not have external bias power, as following further discussion.More particularly, under the situation of using shape memory plastic or elastomeric material, the first arm 206, second arm 208 or the first arm and second arm are configured to radially inwardly pivot to cover needle point.When arm moves, reduced the gap 50 that between two arms, provides.In other embodiments, needle shield 204 is made by many and/or is made by combination of different materials, for example plastics and metal, for example Merlon and rustless steel.

In the ready position of the safety catheter hub 100 shown in Fig. 2, needle shield 204 is positioned at near-end 106 places of catheter hub 102.As shown, needle shield is located substantially on the inside of inner room 104.It can also be arranged in inner room 104 fully or be positioned partially at outside the axially open 110.Pin 202 extends through the hole of needle shield 204 and enters in the inner room 104.Pin distad extends through conduit 112, makes the needle point of pin 202 extend beyond the far-end of duct conduits 112.In ready position, when pin 202 extends through needle shield 204, inclined end portion section 214 is supported on the pin 202, is for example contacted or adjacency by pin, and this causes first free end 210 of the first arm 206 will be pushed or be biased away from second free end 212 of second arm 208.As shown, the cantilever end 212 of second arm 208 also is biased in ready position by pin.

In order in ready position and the tour from ready position to the use location needle shield 204 axially to be positioned in the catheter hub 102, needle shield comprises that hub junction section 64 and hub 102 comprise sheath junction section 66.As shown, hub junction section 64 is that groove and sheath junction section 66 are from the outstanding protuberance of the inner wall surface of hub 102.In another embodiment, structure is turned around, make that hub junction section 64 is that protuberance and sheath junction section 66 are grooves.In one embodiment, it is not circumferential engaging, but only partly around needle shield, make in the arm only one be engaged to hub.In another embodiment, joint is circumferential around needle shield.As shown, hub 102 comprises depression and protuberance.In another embodiment, hub comprise protuberance with formation have the diameter that reduces inner chamber but not the depression.When the inclined end portion section 214 of sheath contacted with pin in ready position, pin pushed away the inclined end portion section radially outwardly with respect to shank, made hub junction section 64 engage sheath junction section 66 so that sheath is remained in the inner chamber of hub 102.

Fig. 2 A is the cross sectional side view of the safety IV C 40 that provides of the embodiment according to this equipment and method.Safety IV C 40 is similar to the safety IV C 100 of Fig. 2, has some exception.Especially, the inner chamber of catheter hub 104 has been modified to and has just comprised at the expansion groove in sheath junction section 66 distally or cave in 42.Expansion groove 42 is configured to adapt to the arc hub junction section 64 on the needle shield 44.As shown, when needle shield 44 was in ready position, sheath junction section 66 was spaced apart with hub junction section 64.Yet when pin 202 was withdrawn away from catheter hub, for example after successful venipuncture, needle shield 44 moved with respect to catheter hub, make hub junction section 64 by relatively moving in abutting connection with or engage sheath junction section 66.This joint continues to move to until needle point the nearside of the inclined end portion section of first and second arms.At this some place, the first arm 206 and second arm 208 radially move inward with closed on needle point.Therefore, the feature of present embodiment is the sheath with hub junction section, and this hub junction section is spaced apart with catheter hub and only engage when relatively moving or in abutting connection with catheter hub in ready position.

If the near-end of needle shield 204 flushes with the near-end 106 of catheter hub 102, perhaps outwards outstanding from the near-end of catheter hub 102, then can be engaged in catheter hub the pin hub be assembled into catheter hub by outer housing (shroud) is provided at pin hub (not shown).In alternate configuration, needle shield 204 is recessed in the catheter hub, and provides the space so that the distal section of pin hub is engaged in the near-end of catheter hub.

In one embodiment, if use shape memory elastic body or the nonmetallic materials that do not have biasing automatically, then can use any type of tensioning that arm 206,208 is biased to together.In other embodiments, use tensioner and the combination of biasing nonmetallic materials automatically.As schematically illustrated in Fig. 3 A, take up member 218 can be deployed in the zone of the needle shield 204 between base portion 205 or proximal wall and first and second free ends 210 and 212.In one embodiment, take up member 218 can be the ring of making by such as the elastomeric material of elastomeric material, silicones etc., and it is formed into and is engaged in around first and second arms 206 and 208.When arm was spaced apart by pin 202, as in ready position, this ring applied restoring force at arm.In one embodiment, take up member 218 can be spring, for example the spring of helical wound spirng, leaf spring or other similar functions types.In one embodiment, take up member 218 can not be the separate part of needle shield 204.In the present embodiment, the one or both in the

arm

206 and 208 can be made by having the intrinsic material that is similar to spring property.The intrinsic character that is similar to spring causes intrinsic restoring force to be stored in the arm at arm during by pin 202 spaced apart (for example being in ready position).In case pin 202 is removed and do not contacted with the first arm 206, and then arm turns back to protected position naturally.For esthetic requirement and/or in order to promote further elasticity to promote installation, can comprise one or more chamfer surfaces 80 and one or more surface character 68, for example recess or groove.In other embodiments, can add undercutting or other surface character to promote the assembling of take up member 218.In one embodiment, helical spring is assemblied on the whole needle shield, makes the axial force of expanding from spring force two arms radially to move inward.

In operation, the distal tip of pin 202 and duct conduits 112 are inserted in the venous patient to set up venipuncture.Thereafter, the health care practitioner manually extracts pin 202 out from catheter hub 102.Can give the positive Luer spare assembling fluid source of intravenous (IV) pipeline that is attached to catheter hub then, this fluid will be administered in the venous patient.

Along with pin 202 is drawn back from patient after successful venipuncture, pin keep with the contacting of the inclined end portion section 214 of needle shield in respect to the slip of duct conduits proximad, so that sheath removably is fixed to hub.In case needle point moves to the nearside of the inclined end portion section 214 of sheath, then the first arm 206(its now no longer by pin to extrapolation) radially move inward so that hub junction section 64 is separated from sheath junction section 66, to cover needle point with inclined end portion section 214.The further nearside of pin moves and impels the profile variations 402(Fig. 2 that is positioned on the shank) opening 207 on the proximal wall of sheath, to stop relatively moving between needle shield and the pin.At this some place, because the adjacency between the opening on this profile variations and the needle shield, needle shield can be from catheter hub.Below further discuss and impel needle shield to separate to protect needle point from the pin hub.

The ordinary construction that is understood that the safety catheter hub 100 of such description provides the following examples that can use needle shield to guarantee suitably and the background of sufficient protection to the health care practitioner who uses safety catheter hub 100 with operation.What will also be understood that is according to circumstances and as required, such as under the situation of function or feature compatibility, and can be individually or use each embodiment that describes in this article in combination with one another.

Refer again to Fig. 3 A, in the embodiment of needle shield 300, can indicate the length of inclined end portion section 214 with variables L n, its, n is integer, such as 1,2,3 etc.Can indicate the width (highly) of inclined end portion section 214 with variable W, it clearly show that in end-view 3B-3B.In one embodiment, length L n and width W are selected as making inclined end portion section 214 to be configured to stop fully needle point when needle shield is in protected position.In a particular embodiment; the length L n of sheath and width W are selected as making needle point to be stopped by end section 214 or cover; even thereby the point that is rotated the inclined-plane when pin is during still in the face of end section 214, even perhaps when pin laterally pivots when being in protected position.In addition, width W and length L n with wide to being enough to prevent that the pin inclined-plane from contacting the edge of inclined end portion section 214 because when being clashed into by the pin inclined-plane, may be cracked such as some plastics of Merlon or ABS.Therefore, the feature of this equipment, assembly and method is a kind of needle shield with nonmetal base portion or proximal wall, this nonmetal base portion or proximal wall comprise the hole, towards the surface of nearside and towards the surface in distally, and wherein, can pivot to make hole and base portion distortion by making pin, because length and the width of inclination distal end section, this type of pivots and does not impel needle point to overflow from the boundary of inclination distal end section but wherein.In one example, length approximately is the size identical with the width W that is used for wide needle shield.In another example, length is about 1.3 times or more times of width W, for example is 2x, 3x or the 4x of width W.Compare with the diameter of pin, width W is the 1.25x of the diameter of pin or bigger preferably, for example is 2.5x, the 3x of the diameter of pin or bigger.

In one embodiment, length L ₁Be selected as making when first and

second arms

206 and 208 are in protected position inclined end portion section 214 outstanding at least a portion of crossing second free end 212.Alternatively, can be with length L ₂Be chosen as and make when first and

second arms

206 and 208 are in protected position inclined end portion section 214 outstanding crossing between at least a portion and whole second free end 212 of second free end 212.In another alternate embodiment, can be with length L ₂Be chosen as and make when first and

second arms

206 and 208 are in protected position, inclined end portion section 214 is outstanding cross and above second free end 212 fully.Therefore; for example; length L n can be chosen as when first and

second arms

206 and 208 are in protected position, impel the outstanding sub-fractions of crossing second free end 212 of inclined end portion section 214,100% sub-fraction of second free end 212 or second free end 212 100% between.

Similarly, the width W of inclined end portion section 214 can be chosen as and make when first and

second arms

206 and 208 are in protected position, inclined end portion section 214 on width W greater than the width of second free end 212.Therefore, for example, width W can be chosen as when first and

second arms

206 and 208 are in protected position the width greater than second free end 212, greater than the width sub-fraction of second free end 212 to about 50% between.It should be understood that the selection that can be independent of other sizes carries out the selection of length L n and width W.As shown in Fig. 3 B, width W and length L n make all the time greater than the D outer diameter of pin 202 no matter how pin is rotating between retirement period or pivoting, and needle point and inclined-plane are tilted end section 214 all the time to be stopped in hole 207.Therefore, when being in protected position, inclined end portion section 214 produces the space in its back, and this space is limited by length and the width of the inclination distal end section 214 bigger than the D outer diameter of pin.In one embodiment, this width is than the diameter of pin greatly at least 125%, and length is than the diameter of pin greatly at least 200%.In other embodiments, width is than the diameter of pin greatly from about 150% to about 300%.Disclosed length and width and in the hole 207 of proximal end is configured to needle point remained on open area 304 in the needle shield.

In order further to help the protection of needle point, the inclined end portion section 214 of needle shield can comprise shield member or insert 306.Shield member 306 can be made by anti-pierceable material, such as metal insert or duroplasts insert.In case when pin had been caught by needle shield 300, shield member 306 stoped inclined end portion section 214 to be pierced through by needle point.For example, when sheath is made by elastomeric material, can for example incorporate shield member 306 into by common molded or inserted mode system, expose to prevent needle point from penetrating inclined end portion section 214.In another embodiment, shield member 306 is positioned on the outer surface of inclined end portion section 214, for example on the distal surface 308 or proximal face 310 of inclined end portion section.Can use any known means that parts are combined that shield member 306 is installed to outer surface, such as gummed, welding etc.

Fig. 3 B is in to be protected or schematic top view or the plane graph of the needle shield 300 of protected position, and it catches needle point 196 in the open area 304 of needle shield.Because needle shield 300 is made by having than the lower intensity of metal material and the nonmetallic materials of hardness at least in part, so pin can pivot along first angle, as with shown in the chain-dotted line 30, perhaps pivot along second angle, as with shown in the chain-dotted line 32.When pivoting, pin can 207 distal side edge place and may make the part compression in hole or distortion with further pivot in abutting connection with corresponding point at

point

34 and 36 place's abutting apertures 207 and/or in the hole.When this took place, needle point 196 kept mobile in the space 304 at limited open space or needle point, and can slide past the lateral edges 38 of needle shield, near inclined end portion section 214.Yet, as discussed above, by selecting suitable width W and length ratio, can prevent that needle point from sliding past lateral edges 38.Alternatively or in addition, hole 207 internal diameters can be manufactured the close fit ratio with contrast shank external diameter, so that the amount that may pivot minimizes.Can also utilize hole length so that the amount that may pivot minimizes with bore dia combinedly.In addition, relative harder insert can be combined with hole 207 or in hole 207 separating force (as following further discussion) not only to increase pin, but also the amount of possible pin pivot is minimized.

Fig. 4 A is the side view that is positioned at the needle shield 400 on the pin 202 when protected position.Except near the profile variations 402 that provides the needle point of the far-end of pin 202, pin 202 has the cross section (being nominal diameter) of substantial constant along the length of pin 202.Profile variations can be considered as have the pin section of the size different with nominal diameter, and can use various means to produce.In one embodiment, can be by along both sides or symmetrically along the circumference of pin or alternatively only the side on the circumference of pin or some place make a part of fold of pin 202 realize profile variations 402.This fold (crimping) process produces recess and produces expansion section along another plane of pin along plane of pin.Can also be by on the outer surface of pin 202, adding material or forming profile variations 402 by adding lining to pin.The material that adds can comprise binding agent, resin or metal material.Like this, profile variations can be called projection, it can comprise a section of pin of material, fold, lining, projection or its combination with interpolation.

As shown in Figure 4A and 4B, the position of the profile variations 402 that forms at the outer surface of pin 202 is selected such that basically to move to about identical time or constantly of inclined end portion section 214 nearsides of the first arm 206 with needle point, profile variations 402 in abutting connection with or close to the side 62 towards the distally of the base portion 205 of needle shield 400.Profile variations 402 or be the size in the wideest hole 207 greater than base portion 205 of profile variations at least.Therefore, the cause owing to the relative size of the opening in profile variations 402 and hole 207 prevents that the needle point of pin 202 from moving to the nearside of base 205.

In certain embodiments, can increase in order to pull-off strength, removal force or the separating force of pin from sheaths separate by insert 404 being attached to hole 207.As shown in Figure 4A and 4B, as directly abut against make needle shield 400 material (for example, plastics, elastomer or TPE) substitute, profile variations 402 can be manufactured at least in part in abutting connection with the insert 404 that can be made of metal, such as rustless steel lining or pipeline.The increase that contacts of the metal between profile variations 402 and the metal insert 404 and metal spurs profile variations 402 during use and passes the required pulling force in hole 207.In another embodiment, as substituting of metal insert, insert can be by making than the harder plastic material of submount material that is used for forming needle tip protector.By insert 404 being attached to the hole 207 of needle tip protector 300, can be so that removal force increase at least 100% on the opening of being made by plastics, elastomer or TPE material.

In one example, found in order to being about 5 newton (N) with pin from the removal force that the Merlon needle tip protector separates.Yet, under the situation of metal needle tip protector, separate more difficultly, and found to realize the removal force of about 20 N or bigger (for example 30 N).Therefore; the feature of this equipment and method is a kind of safety IV C; it comprises pin hub, catheter hub and the needle tip protector of being made by first material, and this needle tip protector has the insert of being made by the second strong material, and this insert is aimed at the proximal open of needle tip protector.Wherein, in order to removal force that pin is separated from needle tip protector than the compared safety IV C that only has the needle tip protector of being made by first material greatly at least 100%.For example, removal force can be bigger by 200% than the compared safety IV C that only has the needle tip protector of being made by first material, 300% or 400%.In specific example, removal force than the compared safety IV C that only has the needle tip protector of being made by first material big about 600%.Therefore, compare with the opening at insertion element, can more easily the proximal wall of needle tip protector or the opening on the base section 205 be enlarged by being positioned at the profile variations on the pin, this converts bigger removal force to.

Therefore, an aspect of safety IVC and method is the multi-piece type needle tip protector, and it is positioned at catheter hub at least in part by making such as first material of elastomer or TPE material.Wherein, the insert of being made by second material that comprises patchhole is coupled to the proximal wall of needle tip protector to form the multi-piece type needle tip protector; and be not combined the similar safety IV C of insert and compare, increase the multi-piece type needle tip protector and comprise the removal force of the pin of profile variations.In a particular embodiment, insert is metallic plate or sheet.This connection can be mechanical, common molded or inserted mode system or bonding, such as by binding agent or laser.In another embodiment, insert is metal lining or pipeline.In another embodiment, compare with the identical safety IV C that does not have insert, the insert increase can make pin with respect to the hole of the proximal wall required power that not inadvertently or otherwise pivots.This insert comprises hole or the opening of aiming at hole or the opening of needle shield.As previously mentioned, insert can be plate or lining, and can with needle shield common molded or inserted mode system, perhaps be attached to the outer surface of needle shield.

This equipment and method be a kind of safety IV C on the other hand, it comprises needle tip protector, this needle tip protector is by making such as first material of elastomer or TPE and having a proximal wall, this proximal wall comprises the opening of limiting hole and at two arms of the distal extension of proximal wall, and one in the described arm comprises and is configured for the inclined end portion section that covers the far-end of another arm in protective position; And the insert of being made by second material that wherein, comprises opening is aimed at the opening of proximal wall.Another feature of safety IV C is the shield member, and this shield member is made by the 3rd material that is different from first material, is coupled to the inclined end portion section.In one example, second material is identical with the 3rd material.In another example, the inclined end portion section is longer and wideer than the far-end of another arm.

Advantageously, use metal insert 404 to increase the size that pulling force allows to reduce profile variations 402.For example, when profile variations is fold, can reduce the fold degree when the base portion 205 pulling profile variations that abut against the nonmetal needle shield with insert 404.Do not have the similar pin size of the nonmetal needle shield of insert to compare with use, this allows to use more conventional duct conduits and fastening sleeve 203(Fig. 2), fastening sleeve 203 is used for duct conduits is attached to catheter hub.In other words, if do not comprise insert, then may require bigger fold to separate from the opening of needle shield preventing, this so that require relatively large duct conduits to hold bigger fold.Therefore, by comprising insert, can come the manufacturing needles fold with industry standard, and needn't make the excessive fold of pin in order to increase removal force, otherwise, make the duct conduits of the corresponding oversized dimensions of the excessive fold requirement of pin and fastening sleeve 203 to hold the fold of expansion.In addition, owing to profile variations can be manufactured lessly when being used for having the needle shield of insert, so it is big relatively to be used for realizing that the in-profile of the pin of suitable fluid flow can be still, this in-profile may reduce owing to excessive fold.Similarly, realizing among the embodiment of profile variations by adding material to pin, can also reduce being added to pin with the amount of the material of generation profile variations.Patient can benefit from the design, and it is configured to allow best fold size and removal force, and needn't make the oversize of pin and duct conduits, and oversize pin and duct conduits may cause more painful venipuncture program.In other words, it has by excessive fold with at the pin that does not have to work with the needle shield of being made by elastomer or TPE under the situation of insert with similar safety IV C() to compare, this equipment and method allow to use relative less pin size.

Refer again to Fig. 4 A, limit needle point and keep space 70 by the free end of the zone of inclined end portion section 214 back, second arm 208 or cantilever end 212 and when laterally pivot travel range with from the plane turnover that limited by Fig. 4 A time of pin 202.By the size of inclined end portion section is set with suitable length and width, the inclined-plane section of needle point or needle point is maintained at needle point and keeps in the space 70, and no matter whether pin pivots hole 207 in or rotate and be with or without insert 404.

Fig. 5 is the side view of the needle shield 500 that provides of another embodiment according to this assembly and method.As shown, the first arm 502 and second arm 504 each can completely or partially be made by metal material.For example, the first arm 502 of needle shield 500 can be made by metal material, but second arm is not that second arm can be made by plastics, elastomer or TPE.Can use known technological means formerly, such as by inserted mode system, welding or the first arm 502 of metal is connected to second arm 504 of needle shield 500 by binding agent.In certain embodiments, the first arm 502 of metal is attached to the base portion 506 of needle shield 500.In an illustrated embodiment, base portion 506 is by making with second arm, 504 identical materials.In other embodiments, base portion 506 is made by metal material.The base portion 506 of various embodiment comprises hole 207, and hole 207 extends through base portion 506 in order to receive pin 202 along axial direction.Base portion 506 also has the wall surface 60 dough-making powder wall surface 62 distad towards nearside.

In one embodiment, the first arm 502 can form by having a strip metal sheet that is similar to spring property.In the present embodiment, but the first arm 502 comprises base section 508 and deflection section 510.Base section 508 is coupled to base portion 506.In one embodiment, the base section 508 of the first arm 502 is against the outer surface of base portion 506.Can use conventional method (such as by binding agent, welding or inserted mode system) that the base section 508 of the first arm 502 is fixed to base portion 506.

In the alternate embodiment shown in Fig. 6, the part of base section 508 that can be by making the first arm 502 produces proximal side 602 around base portion 506 bendings of needle shield with the proximal exterior surface 60 against base portion 506.In the present embodiment, bottom surface 602 limits the hole of locating with one heart with hole 207, to allow inserting pin 202 by hole 207.Bottom surface 602 is configured to increase and spurs profile variations 402 during use fully by the required pulling force in hole 207, i.e. removal force.In another embodiment, bottom surface 602 is inserted into and is molded into needle shield, and is positioned at the inside of base portion 506 or is positioned on the distal wall surface of base portion.Randomly, except bottom surface 602, base portion 506 also comprises insert 404.

Refer again to Fig. 5, but the deflection section 510 of the first arm 502 comprises distally inclined end portion section 512.Inclined end portion section 512 inwardly is, tilts towards second arm 504.Inclined end portion section 512 can have the length of at least one fraction percent to 100% that extends across second arm 504.In one embodiment, inclined end portion section 512 can have roughly V-arrangement, the summit points in axial direction direction of V, and the free supporting leg of V extends along the direction of second arm 504.

In one embodiment, can add one or more rib members 514 to the first arm 502.Rib member 514 is arranged on the first arm 502 to add intensity to this arm.For the intensity of increase is provided, rib member 514 can axially extend along the whole length of the first arm 502, perhaps can only extend along the part of the first arm 502.For example, but the rib member can be basically only extend along the axial length of deflection section 510.But when the deflection section 510 of the first arm 502 by away from 504 biasings of second arm time, rib member 514a increases the amount that the first arm is used for resisting the resistance of biasing.Therefore, when this biasing is removed, but the deflection section 510 of the first arm 502 is back to protected position more rapidly and reliably.In addition, in case be in protected position, but the reinforcement of the first arm of then being realized by rib member 514a 502 makes and is difficult to by mistake make deflection section 510 deflections of the first arm 502 more.

In one embodiment, needle shield 500 can comprise one or a pair of limb (flap) 516.Limb 516 can be included as towards the extension of open area 520 crooked 90 degree or more the first arm 502.Limb 516 is from the first arm 502 extends to open area 520 open space that is limited between the first arm 502 and second arm 504.By this way, limb 516 provides semi-closed to open area 520, and its help is held in needle point and is limited in inclined end portion section 512 back.

Alternatively or in addition, limb 522 can be positioned on the inclined end portion section 512.Limb 522 can be made for the end face of inclined end portion section 512 and the extension of

bottom surface.Limb

516 and 522 can be integrally formed into corresponding the first arm 502 and inclined end portion section 512.Can also limb be attached to corresponding the first arm 502 and inclined end portion section 512 after a while, such as by using binding agent, by to its welding limb or other similar suitable attachment methods of being known in the art by use.

Second arm 504 by the nonmetal embodiment that makes in, can add metal or nonmetal limb 524 to second arm.Can use binding agent or other similar suitable attachment methods as known in the art to add limb 524.Second arm can completely or partially be made of metal.

In each embodiment, limb 516,522 and 524 size are provided so that when first and

second arms

502 and 504 are in protected position, stop needle point to leave open area 520.For example,

limb

516 and 524 distance of can be from each arm to open area extending the longitudinal center line that meets or exceeds needle shield 500 520.In another example, limb 522 can be from inclined end portion section 512 to open area extends 520 and impels limb 522 outstanding distances of crossing the part of pin 202.

More than describe proposed expection be used for setting up pin safety device and correlating method and with complete, clear and definite, succinctly and accurately thereby term makes its those skilled in the art can realize using the best mode of mode and the process of this equipment its realization and use.Yet this equipment is easy to from the modification of structure discussed above and replaces structure, and it is of equal value fully.Therefore, this equipment is not limited to disclosed specific embodiment, and can be with at disclosed some feature combination of embodiment in another embodiment, as long as they are compatible in function.On the contrary, this equipment covers all modifications in the spirit and scope that drop on usually the equipment of expressing with following claim and replaces and construct, and it is pointed out and the theme of claimed equipment clearly especially.In addition, can be implemented in herein suitably disclosed embodiment illustratively under the situation that does not have any element, it is open clearly in this article.

Claims

1. needle assembly comprises:

Nonmetal base portion, described nonmetal base portion comprise wall with hole, towards the surface of nearside and towards the surface in distally; And

Comprise the first free-ended the first arm and comprise second free-ended second arm, described the first arm and described second arm roughly axially extend along distal direction from described base portion, described first free end extends beyond described second free end and comprises the inclined end portion section that extends towards described second arm

Wherein, described inclination distal end section comprises that the pin that is configured to have the pin diameter remains on needle point and keeps length and width in the space; And

Wherein, the length of described inclination distal end section and width are the twice at least of described pin diameter greater than described pin diameter and described width.

2. the needle assembly of claim 1 also comprises metal insert, and described metal insert is arranged in the hole of described needle shield to allow contacting between described metal insert and the profile variations that is adjacent to the needle point location when described pin is in protected position.

3. the needle assembly of claim 1 also comprises the shield member, and described shield member is made by the material different with the nonmetallic materials of described base portion, be arranged in described inclined end portion section or on.

4. the needle assembly of claim 1 also comprises catheter hub, and described catheter hub comprises the sheath junction section that is suitable for engaging the hub junction section on the described needle shield.

5. the needle assembly of claim 4 also comprises take up member, and described take up member is positioned at described needle shield on every side so that described the first arm and described second arm are setovered towards each other.

6. the needle assembly of claim 4 also comprises the port that is positioned on the described catheter hub, and the open proximal end of described port and described catheter hub is spaced apart.

7. the needle assembly of claim 6 also comprises for the lining of control by the fluid flow of described port.

8. the needle assembly of claim 1, wherein, described needle shield on the described the first arm, on described second arm or described the first arm and second arm comprise limb.

9. needle assembly comprises:

Nonmetal base portion, described nonmetal base portion comprise have the hole, the wall of hole length, bore dia, towards the surface of nearside and towards the surface in distally; And

Comprise the first free-ended the first arm and comprise second free-ended second arm, described the first arm and described second arm roughly axially extend along distal direction from described base portion, described first free end extends beyond described second free end and comprises the inclined end portion section, and described inclined end portion section comprises first side edge, second side edge, length and the width that extends towards described second arm;

Needle point keeps the space, and described needle point keeps the space to be limited by described base portion, described the first arm, described second arm and described inclined end portion section at least in part;

Pin, described needle set has needle point and diameter,

Wherein, described the first arm and described second arm are biased, thereby mobile between ready position and protected position, and in described ready position, described inclined end portion section is in abutting connection with described pin, and in protected position, described needle point is limited in needle point and keeps in the space; And

Wherein, the length of described inclination distal end section and width cooperate greater than described pin diameter and with described hole length and described bore dia and keep in the space described needle point is limited in described needle point.

10. the needle assembly of claim 9, wherein, the length by described inclination distal end section and the cooperation between width, described hole length and the described bore dia prevent that described needle point from pivoting and surpass described first side edge or described second side edge.

11. the needle assembly of claim 9 also comprises the cylindrical shape insert of being made by the material different with the nonmetallic materials of described base portion.

12. the needle assembly of claim 11, wherein, described pin comprises profile variations, and wherein, described profile variations is in abutting connection with described insert.

13. the needle assembly of claim 9 also comprises be used to the take up member that described the first arm and described second arm are setovered towards each other.

14. the needle assembly of claim 9 also comprises the shield member, described shield member is made by the material different with the nonmetallic materials of described base portion, is positioned at described inclined end portion section place.

15. a method that is used for the assembling needle assembly comprises;

Provide pin at the pin hub, described needle set has shank, needle point and near the profile variations described needle point;

Place needle shield slidably around described shank; Described needle shield comprises:

The length of wherein, inclination distal end section and width cooperate greater than the pin diameter and with described hole length and bore dia and keep in the space described needle point is limited in described needle point;

Make described needle shield move to proximal position on the described shank, make described inclined end portion section be setovered by described shank and spaced apart with described needle point.

16. the method for claim 15 also comprises described needle shield is placed in the catheter hub, makes sheath junction section on the described catheter hub engage the hub junction section on the described needle shield.

17. the method for claim 16, wherein, described joint only takes place after moving described needle shield with respect to described catheter hub.

18. the method for claim 15 also comprises the insert in the hole that is positioned at described needle shield.

19. the method for claim 18 also comprises against described insert and moves described profile variations.

20. the method for claim 19 wherein, is at least 3 times of similar needle shield that do not have insert away from the separating force of described needle shield in order to spur described profile variations.

21. a needle assembly, the pin hub that comprises pin, is installed in the needle shield on the described pin and is attached to described pin; Wherein, described needle shield is partially or even wholly made by nonmetallic materials.